FDAnews Device Daily Bulletin

Inadequate GMPs Garner Warning Letter for Italian Devicemaker

April 15, 2013
An Italian manufacturer of laser devices was hit with a Form 483 and warning letter after an FDA inspection detected multiple problems with the company’s documentation practices. The FDA inspected Fisioline s.r.l.’s Verduno, Italy, facility between Oct. 29 and Nov. 1, 2012, filing a nine-observation Form 483 upon conclusion.
Devices & Diagnostics Letter